Formulation-First Thinking: The Science of Better Drug Delivery

Formulation challenges continue to rise as new chemical entities become more complex, more potent, and more difficult to solubilize. Ascendia Pharmaceutical Solutions applies a formulation-first development model designed to address these challenges at the earliest stage. This approach focuses on selecting the right formulation strategy based on a compound’s intrinsic properties, the target product profile, and the intended route of administration.

Formulation-first thinking improves the probability of technical success, reduces material waste, and accelerates timelines for pharmacology, toxicology, and early clinical studies.

A Model Built on Technical Ownership

Ascendia Pharmaceutical Solutions applies a lead-formulator and lead-analyst team model for every development program. Each project is treated as personal ownership by the scientists responsible for it. This means the same formulation and analytical leadership remains accountable from feasibility through Phase I and Phase II development.

The team structure provides tight alignment between formulation decisions and analytical method development. Analytical scientists adapt or design methods early so that testing can begin as soon as the compound is synthesized. This reduces delays and prevents rework when new chemical entities have limited historical data.

This integrated ownership model allows Ascendia Pharmaceutical Solutions to move rapidly, make informed formulation decisions, and maintain consistent communication with sponsors.

A Portfolio of Proven Solubility-Enhancing Technologies

Modern drug candidates often present challenges in solubility, permeability, and stability. Ascendia Pharmaceutical Solutions uses four technology platforms to address these issues:

• AmorSol® for amorphous solid dispersions using spray drying or hot-melt extrusion.
• NanoSol® for nanosuspensions and particle size reduction.
• EmulSol® for nanoemulsions, microemulsions, and lipid-based systems.
• LipidSol® for lipid-based formulations designed for specific biological modalities.

No single technology can address every solubility challenge. Each compound undergoes evaluation based on melting point, lipophilicity, solubility behavior, dose requirements, and route of administration. These data guide a decision tree that directs formulators toward the most appropriate platform.

Ascendia Pharmaceutical Solutions tailors each formulation to enable rapid in vivo evaluation and to support early proof-of-concept milestones. This enables efficient progression from discovery to toxicology and IND-enabling studies.

Faster Timelines Through Early Analytical Integration

Early integration of analytical development is essential to the formulation-first model. Analytical scientists assess stability, solubility, and assay requirements as soon as the compound is available. When compounds are brand new, the analytical team designs methods specifically for the molecule’s chemistry rather than adapting generic protocols.

This collaboration reduces the time required to complete feasibility batches, conduct early in vitro testing, and prepare material for in vivo studies. It also helps conserve valuable API when supply is limited, which is common during discovery and early development.

Capabilities Designed for High-Risk and High-Complexity Molecules

Many sponsors approach Ascendia Pharmaceutical Solutions after encountering challenges at other CDMOs. The company’s formulation-first methodology and platform technologies often enable progress where previous attempts have not succeeded.

Projects involving low-solubility molecules, high melting points, unstable actives, or incompatible excipients benefit from the company’s platform depth and experience. Through its technology and scientific depth, Ascendia Pharmaceutical Solutions has helped sponsors raise capital, file INDs, and move into clinical stages. Its ability to “make the impossible possible” enables therapies for unmet medical needs.

For many sponsors, this capability influences fundraising, program continuation, and overall development strategy.

End-to-End Support From Discovery Through Early Commercialization

Ascendia Pharmaceutical Solutions integrates formulation development, analytical testing, and manufacturing within a single organization. This includes scale-up from feasibility to GMP manufacturing for Phase I, Phase II, and early Phase III studies.

The ability to execute formulation, development, scale-up, and manufacturing in one location reduces the risk associated with technology transfer. It also provides continuity that supports consistent product quality and regulatory readiness.

This structure is a major differentiator among CDMOs, particularly for early-stage companies seeking a streamlined path to first-in-human studies.

A Culture of Excellence (“BEST” Philosophy)

Our corporate culture centers on its BEST philosophy: Brilliant Technology, Excellent Service, Superior Quality, and Trust. These principles guide every project.

• Brilliant Technology: proprietary enabling platforms.
• Excellent Service: dedicated, cross-functional project teams aligned with sponsor goals.
• Superior Quality: cGMP manufacturing and quality systems built to scale.
• Trust: clients receive partnership-level engagement, not just transactional service.

Advanced Sterile and Aseptic Manufacturing

Ascendia Pharmaceutical Solutions’ aseptic fill-finish capabilities support nanoemulsions, lipid nanoparticles, and nanosuspensions in vials, prefilled syringes, and cartridges. The cleanroom suites operate under ISO-5 and ISO-7 conditions. These capabilities, combined with proprietary nanomilling and microfluidic systems, support sterile manufacturing at scales from one vial to tens of thousands.

Advancing With Digital Tools and Applied Innovation

Formulation-first thinking continues to evolve. Ascendia Pharmaceutical Solutions is integrating digital tools, electronic documentation systems, and cloud-based workflows to increase transparency and efficiency. The organization is evaluating how artificial intelligence may enhance material selection, formulation optimization, and decision-making during feasibility and scale-up.

The company continues to invest in manufacturing expansion and digital infrastructure to support future growth and readiness for late-stage commercialization needs.

Ascendia Pharmaceutical Solutions Delivers the Science Behind Better Drug Delivery

Sponsors developing poorly soluble or complex molecules require a partner capable of solving first-principle formulation challenges. Ascendia Pharmaceutical Solutions provides the technologies, scientific depth, and integrated structure required to move challenging compounds into clinical development.

Formulation-first thinking reduces risk, accelerates timelines, and conserves precious API. This model enables drug developers to test novel molecules more quickly, make informed go/no-go decisions, and advance promising drug candidates into preclinical and clinical stages with confidence.

Ascendia Pharmaceutical Solutions supports discovery-stage companies, emerging biopharma organizations, and global pharmaceutical companies with formulation development, analytical testing, and GMP manufacturing.

Engage Ascendia Pharmaceutical Solutions

Organizations seeking to accelerate development timelines, overcome solubility challenges, or advance a stalled program can engage Ascendia Pharmaceutical Solutions for technical evaluation and project planning. Contact Ascendia Pharmaceutical Solutions to schedule a meeting and discuss how its formulation-first model can support your molecule’s path to the clinic.